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Maxima I

by Staodyne, Inc.

510(k) K931424

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK931424 Date4 Jun 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GZJ
Device Class
Class II
Regulation
21 CFR Part 882.5890
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Maxima I is a Stimulator, Nerve, Transcutaneous, For Pain Relief, classified under FDA product code GZJ. This device delivers transcutaneous electrical nerve stimulation (TENS) to alleviate chronic pain by modulating nerve signals through low-voltage electrical impulses.

Supplied as a reusable medical device, the Maxima I is intended for use in clinical and home settings under professional supervision. It requires no sterilisation and is regulated under FDA 510(k) clearance (K931424), granted as substantially equivalent to predicate devices in 1993. Compliance with FDA classification 2 and neurology review standards applies.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Maxima I device used for?

    The Maxima I is a transcutaneous electrical nerve stimulation (TENS) device designed to alleviate chronic pain by delivering low-voltage electrical impulses to modulate nerve signals. It is intended for use in both clinical and home settings under professional supervision.

  • Is the Maxima I a single-use or reusable device?

    The Maxima I is supplied as a reusable medical device, meaning it is designed for multiple uses over time. It does not require sterilisation between uses, as it is intended for transcutaneous application with proper skin preparation and electrode care.

  • How is the Maxima I regulated in the United States?

    The Maxima I is regulated under FDA 510(k) clearance, specifically under submission K931424, which was granted on June 4, 1993. It was determined to be substantially equivalent to predicate devices and is classified under FDA product code GZJ for neurology-reviewed devices.

  • What type of FDA review pathway was used for the Maxima I?

    The Maxima I received clearance through the Traditional 510(k) pathway, as indicated by the clearance_type field in the device data. This route requires demonstrating substantial equivalence to a legally marketed predicate device.

  • What advisory committee was involved in the review of the Maxima I?

    The Maxima I was reviewed under the Neurology advisory committee, as indicated by both the advisory_committee and review_advisory_committee fields showing 'NE', which corresponds to Neurology in FDA classification systems.